Data were collected from 7months before until 7months after switching treatment. afK ] T z"$qu9H$}W//~||!+iO7^Q)|F.j+m ZJ7CY\7\lO7OGPno? Anemia: an early complication of chronic renal insufficiency. Among patients switched from DA to PEG-Epo, the mean monthly PEG-Epo dose was increased from 159g at the switch to 263g at Week 26 and 273g at Month 1112 [11]. Use the lowest Mircera dose sufficient to reduce the need for red blood cell (RBC) transfusions. This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration. 2023Vifor (International) Inc. All rights reserved. Each dosage strength of MIRCERA is designated by a unique syringe plunger color. Over the last 25years, several originator and biosimilar ESAs have been introduced for the management of CKD anemia, starting with the first generation short-acting recombinant erythropoietin agents (epoetin alfa and beta) and latterly with two longer-acting molecules, darbepoetin alfa (DA) and methoxy polyethylene glycol-epoetin beta (PEG-Epo), which combine a significantly increased half-life and lower binding affinity for the EPO receptor, allowing them to stimulate erythropoiesis for longer periods and to be administered less frequently [5, 6]. . The majority of patients who were transfused during the pre- and post-switch observation periods had Hb 10g/dL within the 14days prior to transfusion; only 1 patient during each period had Hb >11g/dL within the 14-day pre-transfusion interval. risks. Bland JM, Altman DG. Mircera is used to reduce or avoid the need for RBC transfusions. No difference in conversion dosage could be determined between patients who were epoetin sensitive (<200 units/kg per week) or resistant (>200 units/kg per week, P = NS). Please know that Amgen, the sponsor of this site, is not responsible for the content on the site you are about to enter. Methoxy polyethylene glycol-epoetin beta injection is used to treat anemia in adults with chronic kidney disease (CKD) who may or may not be on dialysis or in children with CKD who are on dialysis. 2009 Nov-Dec;15(9):741-50. doi: 10.18553/jmcp.2009.15.9.741. Empirical methods to calculate an erythropoiesis-stimulating agent dose conversion ratio in nondialyzed patients with chronic kidney disease. Disclaimer. Conversion from darbepoetin or erythropoietin to Mircera 1. In the absence of PRCA, follow dosing recommendations for management of patients with an insufficient response to MIRCERA, Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in the postmarketing setting in patients treated with MIRCERA, PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which MIRCERA, If severe anemia and low reticulocyte count develop during treatment with MIRCERA, Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, tachycardia, pruritus, skin rash and urticaria have been reported in patients treated with MIRCERA, Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including MIRCERA, Patients may require adjustments in their dialysis prescription after initiation of MIRCERA, Most frequent adverse reactions ( 5%) in adult patients with CKD treated with MIRCERA. 2). Am J Kidney Dis. Mechanism of Action. sharing sensitive information, make sure youre on a federal Further exploration of the relationship between DA and PEG-Epo doses using the BlandAltman method [10], which circumvents the limitations of the regression method in this type of investigation, indicated that the variability in the dose differences increased as doses increased, while the level of concordance decreased with increasing ESA dose. The enrolling dialysis centers were situated in France, Germany, Spain and the UK, and each was expected to enroll a minimum of 20 patients into the study. If you are a healthcare professional outside of the US, please, visit www.mircera.global, The rate of hemoglobin decline indicates the likelihood of requiring a RBC transfusion, and, Reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal, For adverse event reports, please contact us at, You may also report negative side effects of prescription drugs to, the Food and Drug Administration (FDA). Anemia Associated with Chronic Renal Failure, Methoxy polyethylene glycol-epoetin beta 30ug in 0.3mL, Drug class: recombinant human erythropoietins. Kazmi WH, Kausz AT, Khan S, et al. Nephrol Dial Transplant. Packaging Size: 0.3 ml. Firstly, the study sample was drawn largely from a single country (France), which contributed over 70% of the patients and 10 of the 14 study sites. Macdougall IC. The long-acting r-HuEPO methoxy polyethylene glycol-epoetin beta (Mircera) has been associated with a risk of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) following a. Medically reviewed by Drugs.com. More severe cases were recorded with long-acting agents (darbepoetin alfa and methoxy polyethylene glycol-epoetin beta). -. Hrl WH. There is no evidence that Mircera alters the metabolism of other medicinal products. Conversion from Epoetin alfa or Darbepoetin alfa to MIRCERA in Pediatric Patients with CKD on Hemodialysis. The primary outcome (DCR) for each patient was calculated as the mean weekly dose of PEG-Epo during the post-switch EP divided by the mean weekly dose of DA during the pre-switch EP. Eschbach JW, Adamson JW. The intravenous route is recommended for patients on hemodialysis because the intravenous route may be less immunogenic. ESA erythropoiesis-stimulating agent, Hb hemoglobin. W\iA* Anemia response to Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) versus Epoetin Alfa (Eprex) in patients with chronic Kidney disease on Hemodialysis Published: September 05, 2017 42/47 is common in patients with a GFR below 30 ml/min/1.73m2 and contributes to many of the speciic symptoms of CKD. EP evaluation period, PEG-Epo methoxy polyethylene glycol-epoetin beta. Kidney Med. Following administration, remove the needle from the injection site and then release the plunger to allow the needle guard to move up until the entire needle is covered. Nephrol Dial Transplant. Studies of erythropoietin therapy in patients with chronic anemia of cancer as well as CIA document response rates ranging from ~60% to 85%. 6). doi: 10.1038/ki.1985.109. 2004;19(Suppl 2):ii1631. Regardless of possible differences in their clinical characteristics it should be borne in mind that patients were not selected for inclusion in the DCR analysis on the basis of their fulfilling any clinical, Hb or ESA dose requirements: all patients who had Hb measurements in both EPs, a DA dose in the pre-switch EP and a PEG-Epo dose in the post-switch EP were eligible for inclusion. Full Prescribing Information, including Boxed WARNING, full Prescribing Information including Boxed WARNING, How to Use the MIRCERA Prefilled Syringe, Healthcare Provider and Patient Resources, full Prescribing Information, including Boxed WARNING. Correct or exclude other causes of anemia (e.g., vitamin deficiency, metabolic or chronic inflammatory conditions, bleeding, etc.) Dr. Peter Choi is the guarantor for this article, and takes responsibility for the integrity of the work as a whole. Mircera is not the same as epoetin alfa (Procrit, Epogen). This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. St. Gallen, Switzerland: Vifor (International) Inc.; June 2018. The https:// ensures that you are connecting to the Bookshelf Peter Choi. No trial has identified a hemoglobin target level, ESA dose, or dosing strategy that does not increase these risks. a Mutually exclusive categories; patients are censored in the following, Analysis of relationship between pre- and post-switch erythropoiesis-stimulating agent dose. MIRCERA Interactions: May require increased anticoagulation (heparin) during hemodialysis. An official website of the United States government. Open Access This article is distributed under the terms of the Creative Commons Attribution 2.0 International License (https://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Careers. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. In an additional analysis performed to assess the sensitivity of this result to the effects of transfusion by excluding those patients who received an RBC transfusion within 90days prior to or during either evaluation period, the DCR was 1.21 (95% CI 1.09, 1.35). Do not use any prefilled syringes exhibiting particulate matter or a coloration other than colorless to slightly yellowish. Brand: Mircera. Strength: 100 mcg / 0.3ml. Conversion from Epoetin alfa or Darbepoetin alfa to Mircera in Adult Patients with CKD. Introduction: ferrous sulfate, Aranesp, Procrit, Retacrit. Secondary outcomes included Hb concentrations and ESA use during the study period, and the incidence of red blood cell (RBC) transfusions. doi: 10.1093/ndt/17.suppl_5.66. Mircera (methoxy polyethylene glycol / epoetin beta) dosing, indications, interactions, adverse effects, and more Drugs & Diseases methoxy polyethylene glycol / epoetin beta (Rx) Brand and. Always store Mircera prefilled syringes in their original cartons. The geometric mean weekly ESA doses were 24.1g DA in the pre-switch EP and 28.6g PEG-Epo in the post-switch EP. . Editorial assistance in the preparation of this manuscript was provided by W. Mark Roberts, PhD, Montreal, Canada. AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo. There were 16 transfusion events in the pre-switch period and 48 post-switch, with a total of 34 units transfused pre-switch and 95 units in the post-switch period (Fig. Conclusion: A dose approximating 0. 2002;162:14011408. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency. Conclusion: MIRCERA [prescribing information]. endobj The majority of patients with CKD will require supplemental iron during the course of ESA therapy. I certify that I am a healthcare professional in the US. In particular, the likelihood of a transfusion during the post-switch period was significantly higher in patients with a dose ratio below 1 at switch.
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